Recent Development

The Turkish Medicines and Medical Devices Agency ("TİTCK") recently published on its website the list of the certified pharmacovigilance service providers.

What is Pharmacovigilance?

Pharmacovigilance refers to the scientific activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. In this scope, marketing authorization holders may fulfill their pharmacovigilance obligations by appointing pharmacovigilance service providers. Such services providers must obtain the approval of the TİTCK to provide pharmacovigilance services.

The list of the approved and certified pharmacovigilance service providers is available here (in Turkish).

Conclusion

Pharmacovigilance is a critical obligation for marketing authorization holders to ensure the safety of the medicinal products. Pharmaceutical companies, therefore, should periodically follow the announcements made on the TİTCK's website and take the necessary steps to ensure compliance.